MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINEMAP 3D 3.0 - SOFTWARE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 6002-670-000

Device Problem Imprecision (1307)

Patient Problems Hematoma (1884); Neuropathy (1983)

Event Date 11/12/2020

Event Type  Injury  

Event Description

It was reported that during a procedure at the user facility the surgeon using the spinemap 3.0 software to navigate for guidewire placement noted an inaccuracy issue when establishing patient landmarks, but preferred making reference to medial-lateral coordinate while using the device.After placing the guidewires, the surgeon used an x-ray scan and found that the guidewires were positioned differently than intended.It was reported the patient needed a blood transfusion, experienced a hematoma, and that the surgery was delayed for one hour.During the delay between procedures, it was reported the patient's blood pressure dropped.An additional surgery was conducted to re-position the guidewires using x-ray guidance for placement and to treat the hematoma.The revision surgery was completed successfully, no further adverse events or medical intervention has been reported.

Event Description

It was reported that during a procedure at the user facility the surgeon using the spinemap 3.0 software to navigate for guidewire placement noted an inaccuracy issue when establishing patient landmarks, but preferred making reference to medial-lateral coordinate while using the device.After placing the guidewires, the surgeon used an x-ray scan and found that the guidewires were positioned differently than intended.It was reported the patient needed a blood transfusion, experienced a hematoma, and that the surgery was delayed for one hour.During the delay between procedures, it was reported the patient's blood pressure dropped.An additional surgery was conducted to re-position the guidewires using x-ray guidance for placement and to treat the hematoma.The revision surgery was completed successfully, no further adverse events or medical intervention has been reported.

Manufacturer Narrative

Additional information added for d4, d10, h3, h4.Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: SPINEMAP 3D 3.0 - SOFTWARE
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11015475
• MDR Text Key: 221724427
• Report Number: 0001811755-2020-03463
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 07613327114898
• UDI-Public: 07613327114898
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6002-670-000
• Device Catalogue Number: 6002-670-000
• Device Lot Number: 3.0-45/046
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention